BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 21856849 · Received April 17, 2025

    Report

    Report Number
    9611451-2025-00339
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Report Date
    June 16, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    UDI-DI
    09420012410979
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FISHER AND PAYKEL HEALTHCARE (F&P) ARE CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: RD900ALU NEOPUFF INFANT RESUSCITATOR IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE, USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K971965. METHOD: THE SUBJECT RD900 NEOPUFF INFANT RESUSCITATOR WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION AND PHOTOGRAPHY PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF OUR PRODUCT. RESULTS: THE CUSTOMER REPORTED THAT THE INLET PORT OF THE RD900 NEOPUFF INFANT RESUSCITATOR WAS DAMAGED. VISUAL INSPECTION OF THE PHOTOGRAPH PROVIDED BY THE CUSTOMER SHOWED THAT THE INLET PORT OF THE RD900 NEOPUFF INFANT RESUSCITATOR WAS OBSERVED BROKEN FROM THE FASCIA. CONCLUSION: OUR INVESTIGATION WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED FAULT. THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANTS UNTIL ADEQUATE SPONTANEOUS BREATHING OCCURS. BEING A PORTABLE DEVICE, THE NEOPUFF CAN BE SUSCEPTIBLE TO IMPACT DAMAGE, FOR INSTANCE WHEN ACCIDENTALLY DROPPED OR SUBJECTED TO CONSIDERABLE EXTERNAL FORCE. THE NEOPUFF TECHNICAL MANUAL WARNS AGAINST DROPPING THE NEOPUFF OR SUBJECTING IT TO IMPACT DAMAGE WHICH MAY CAUSE THE UNIT TO OPERATE INCORRECTLY. IF THE NEOPUFF IS SUSPECTED TO HAVE BEEN DAMAGED, THE MANOMETER AND VALVE SYSTEM SHOULD BE PERFORMANCE TESTED. IN ADDITION, THE NEOPUFF USER INSTRUCTIONS STATE THAT THE USER SHOULD "CHECK MANOMETER READS ZERO WITH NO GAS FLOW" AND CHECK THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF". AS MENTIONED, THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: - DROPPING THE NEOPUFF / PERIVENT INFANT RESUSCITATOR OR OTHER SIMILAR FORMS OF IMPACT MAY CAUSE DAMAGE RESULTING IN INCORRECT OPERATION OF THE UNIT. IF YOU SUSPECT DAMAGE TO HAVE OCCURRED, PLEASE PERFORM CHECKS AS OUTLINED [IN THE MANUAL] BEFORE CONNECTION TO A PATIENT. EACH NEOPUFF UNIT IS ASSEMBLED AND 100% TESTED IN THE PRODUCTION LINE TO VERIFY THAT EACH UNIT CONFORMS TO CRITICAL PRODUCT SPECIFICATIONS. ANY UNIT THAT FAILS IS REJECTED. THE SUBJECT NEOPUFF WOULD HAVE MET THE REQUIREMENTS AT THE TIME OF PRODUCTION.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN ITALY REPORTED ON BEHALF OF ANOTHER DISTRIBUTOR VIA A DISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE RD900 NEOPUFF INFANT RESUSCITATOR HAD A DAMAGED OXYGEN INLET PORT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN ITALY REPORTED ON BEHALF OF ANOTHER DISTRIBUTOR VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE RD900 NEOPUFF INFANT RESUSCITATOR HAD A DAMAGED OXYGEN INLET PORT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20795 FISHER & PAYKEL HEALTHCARE INFANT RESUSCITATOR FMT FISHER & PAYKEL HEALTHCARE LTD RD900ALU 2100031012 09420012410979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown